A third Covid vaccine is likely to be approved for use in Britain next week but it will not be available until April because the UK is no longer part of the EU.
Britain has ordered 7m doses of the Moderna vaccine, which has been approved by regulators in the EU and US. But UK authorisation will not help the government towards its goal of vaccinating the most vulnerable by mid-February.
The post-Brexit trade deal agreed on Christmas Eve has been overwhelmingly backed by the UK parliament, providing some degree of stability – but also plenty of disruption – for the coming months and years.
The UK is leaving the EU’s single market and customs union, but the deal means tariffs on goods won’t be imposed when the transition period ends at 23:00 GMT tonight.
In a marked divergence from the wrangling and acrimony that surrounded votes on the withdrawal agreement a couple of years ago, the EU (Future Relationship) Bill was backed by 521 votes to 73 last night.
Prime Minister Boris Johnson said the deal – which comes four-and-a-half years after the UK voted to leave the EU in a referendum – will “fulfil the sovereign wish of the British people to live under their own laws, made by their own elected Parliament.”
The new regime has been welcomed by pharma organisations on both sides of the English channel, although there are still a lot of unanswered questions about what it will mean in practice for the regulation and trade in medicinal products.
With the text of the 1,200-page document now available, it has been confirmed that there will be mutual recognition between the two parties, which means that inspections and certification of good manufacturing practice (GMP) facilities by the UK regulatory authority will be recognised by the EU, and vice versa.
What appears to be missing at first glance from the document however is mutual recognition of safety and quality testing, which might mean some duplicate tests are needed.
The appendix on medicines does however refer to “the exchange and acceptance of official GMP documents between the parties,” and includes an article covering “regulatory cooperation” on changes to technical regulations or inspection procedures.
To make that easier, a Working Group on Medicinal Products will be set up to monitor the impact of the deal on medicines in the UK and EU, for example to respond if there is a threat to medicines supply or public health, and organise future cooperation in areas like scientific or technical guidelines.
BioIndustry Association (BIA) chief executive Steve Bates said after the deal was agreed that it provides “much desired certainty for our sector” after four years of negotiation, although the trade body is still working through the details of the text.
BIA said that traders can self-certify the origin of goods sold and enjoy “full cumulation”, making it easier to comply with requirements and obtain zero-tariff access, adding that there will be specific facilitation arrangements for pharmaceuticals and chemicals.
We are pleased no deal has been avoided between the UK and EU and look forward to examining the trade deal announced today in detail. We will focus on what continued co-operation in Research and Innovation means for our sector and provide full analysis as soon as possible.
The appendix on medicinal products is far from detailed – in fact, Labour Leader Keir Starmer has described the entire document as “thin”, whilst also instructing his party to back it in the parliamentary vote to prevent no deal.
There are other encouraging points for the life sciences, according to the BIA, including the UK continuing to have access to the Horizon Europe Research and Innovation programme as a paying third country.
“We look forward to working with the UK government on this positive agenda, mindful of the fact that our sector seeks, and benefits from, innovative global standards and regulatory collaboration and co-operation,” said Bates.
A joint statement released by the Association of the British Pharmaceutical Industry (ABPI) and European Federation of Pharmaceutical Industries and Associations (EFPIA) – representing the UK and EUK pharma industries – also said it would take time to examine the details of the agreement.
“We have always said that a deal is in the best interest of patients in the UK and the EU,” they said, adding: “regardless…the end of the transition means there will be a significant change in how border and customs arrangements work come Jan 1st and companies have been working on contingency plans to mitigate any disruption.”
Flurry of MHRA guidance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has already started publishing guidance on how things will change from Friday.
This week, for example, it confirmed it will set a 150-day assessment timeline for new medicines, whilst also providing details of its equivalent to the EMA’s “rolling review” designed process to speed up access to novel medicines.
It has also provided updates on the processes needed to submit changes to marketing dossiers for medicinal products, as well as for amendments to clinical trials.
Analysis: From retail to aviation to pharmaceuticals, we look at what will change from 1 January
After months of tortuous negotiations between the UK and the EU, a Brexit trade deal was agreed at almost the last minute. But how prepared are UK businesses for the significant changes that will come into force on 1 January? Are they happy with the terms of the agreement?
NHS leaders have written to the UK prime minister urging him to extend the Brexit transition period by a month to avoid plunging the healthcare service into chaos on 1 January.
The letter, published today by the NHS Confederation – a membership organisation representing NHS leaders from all parts of the health service, outlines concerns about the impact a no-deal outcome will have on delivering care to patients amid winter pressures and a rapid rise in COVID-19 infections.
“The failure to secure a Brexit deal will throw the NHS into further chaos and it will risk the health of patients and the working conditions of our staff,” wrote NHS Confederation chief executive Danny Mortimer. “The NHS might not be perceived to be on the Brexit negotiating table, but the disruption shockwaves from a no-deal outcome could push the NHS’ ability to function over the edge.”
The south east of England is expecting the worst impact, as ambulances and clinicians trying to reach patients face delays due to major congestion on the roads of Kent.
Mortimer added: “They will face these barriers to their critical work while facing some of the highest levels of COVID-19 infections and the additional risks that the increased traffic, lorry parks and congestion could increase the demand for NHS services in the South East. The South East will face disruption even if a deal is reached. Should a deal not be reached, the magnitude and extent of disruption will be of a much greater order.”
Other areas of concern for the NHS Confederation include medical supply shortages, lack of clarity on rules and reimbursement arrangements for EU citizens requiring treatment in the UK and the loss of participation in EU-wide data-sharing platforms to exchange information about health threats and the testing of new treatments.
Meanwhile, new research from the Nuffield Trust and academics from the Universities of Oxford, Sheffield and Michigan warns of a “perilously uncertain” future facing the UK health sector at the end of the Brexit transition period.
Their study examined nine areas of possible impact: health systems delivery, health systems workforce, medical supplies, health systems financing, leadership and governance, communicable diseases, non-communicable diseases, public health capacity and governance.
It highlights how a combination of migration barriers, an unknown level of disruption to medicines and devices, a prolonged economic slowdown, and barriers to investment in science will impact the health sector almost “immediately and into the future”.
Mark Dayan, Brexit programme lead at the Nuffield Trust, said there were many serious questions that needed answering over the future of the sector beyond the UK’s exit from the European Union.
“There are a particular set of fairly immediate issues which should be in sharp focus – from the double whammy of COVID-19 and Brexit-related workforce shortages and economic fallout to the very real danger of supply chains of medicines and medical devices being disrupted.
“But it doesn’t end there. There are some deeply concerning and unresolved issues that may affect health in the UK over many years to come and potentially risk the health of the UK population.”
Companies are praying a trade agreement can be struck, but must prepare for talks to fail. Which will be most affected?
The scene is set for a showdown, and the future of the UK economy is at stake. Will Britain secure a free trade deal with the EU? Or will the prime minister choose to sail into uncharted waters, not only stepping outside the single market and customs union, as the UK will be even under a deal, but adding the tariffs and border checks that come with a no-deal Brexit?
Armed with a determination to end the transition period on 31 December, Boris Johnson is poised to force British businesses to sell their goods and services across the EU without any of the benefits that a deal offers, and with only a few days’ notice. Here we assess the impact on some of the worst-hit industries of securing a deal – albeit a slimmed-down one – compared with the alternative.
The UK and EU have reached an agreement on border checks for Northern Ireland that should guarantee that trade in medicines and food continues without disruption after 1 January – regardless of whether eleventh-hour negotiations result in a trade deal.
The agreement means that the UK government will not press ahead with plans to override parts of the Withdrawal Agreement in order to prevent a border down the Irish Sea, which would have broken international law.
The agreement is separate to the post-Brexit trade deal talks, which appear to be at an impasse at the moment, but remove one complication and could build goodwill between the negotiating teams.
Details of the agreement have yet to be released, but in a statement the two sides said it covers issues including the supply of medicines, border checks on animal and plant products, and deliveries of chilled meats and other food products to supermarkets. There was also “clarification” on the application of rules on state subsidies.
As a result, the UK has said it will withdraw clauses of the UK internal market bill, and will not introduce any similar provisions in a forthcoming taxation bill, that would have rewritten the Withdrawal Agreement to protect trade between Great Britain and Northern Ireland.
The EU has previously threatened to take legal action if those earlier proposed changes had been implemented.
The agreement follows talks in Brussels between Cabinet Office Minister Michael Gove and EU commissioner Maroš Šefčovič as part of the EU-UK Joint Committee, but with details currently scant, some NI politicians have said they are worried about the potential for the EU to have continued influence in their jurisdiction.
As part of the agreement there will be an EU presence in Northern Ireland to monitor implementation of the protocol at the border, which has been slammed by the Democratic Unionist Party (DUP).
The government said today that 98% of GB businesses exported to NI will not face any tariffs, and items shiped into the EU via NI will also largely be expempot from levies.
Efforts to reach an accord on a broader trade deal to come into effect on 1 January when the Brexit transition period comes to an end remain deadlocked over fishing rights, business competition rules and how any trade deal would be enforced in future.
UK Prime Minster Boris Johnson is scheduled to meet with EU Commission President Ursula von der Leyen this evening to try to make a breakthrough in the talks.
I am delighted that we now have an agreement in principle on all the outstanding issues regarding the Withdrawal Agreement.
Gove told ITV News that businesses in Northern Ireland “have the opportunity to enjoy the best of both worlds; access to the European single market… and at the same time unfettered access to the rest of the UK market.”
When it comes to the regulation of medicines, several weeks ago the UK and EU agreed a phased process for implementing medicines regulation in Northern Ireland for an additional year, i.e. up to 31 December 2021, to avoid an abrupt change in the rules.
Under the terms of that earlier agreement, the EU pharmaceutical regulatory framework will continue to apply in Northern Ireland from 1 January, but would be enforced by the UK Medical and Healthcare products Regulatory Agency (MHRA).
Great Britain – which is the supply route for 80% of medicines used in Northern Ireland – will no longer have to comply with EU regulations if no trade agreement is forthcoming.
The 12-month period will provide additional time needed for businesses to prepare for changes to batch testing, importation, and the need to scan a unique identifier on medicine packs at the point of dispensing to protect patients from falsified, expired or recalled drugs – part of the EU Falsified Medicines Directive.
The UK’s pharma industry trade body has warned that Brexit could derail the government’s efforts to get coronavirus vaccines to the population, but welcomed other measures in this week’s spending review aimed at reviving the economy after the pandemic.
In the build-up to chancellor Rishi Sunak’s announcement in the House of Commons, the Association of the British Pharmaceutical Industry (ABPI) chief executive Richard Torbett warned that a no-deal Brexit could disrupt supplies of vaccines.
He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation.
Brexit talks are on a knife edge as the transition period nears its end and the EU’s chief negotiator Michel Barnier has threated to pull out of negotiations in London this weekend unless the UK changes its stance on issues such as fishing and state aid.
Torbett said: “We are as prepared as we can possibly be, but we don’t need this extra red tape, extra complexity, extra cost and extra delay getting in the way of our supply chain at a time where we’re trying to deal with COVID.
“Clearly this is very frustrating and all of the time and effort and resource that has been put into the multiple levels of scenario planning around Brexit is time and effort and resource that could have been put to other better uses.”
The ABPI had better things to say about the spending review, however.
The industry welcomed £3 billion pledged to support the NHS from the impact of COVID-19 and noted a £14.6 billion funding boost to help the UK grow as a leader in science and technology.
Torbett said in a statement: “As the government focuses on its growth agenda, it should look to life sciences and make the most of this funding to unlock the future potential of our sector.
“Policies that encourage investment into cutting-edge research – such as delivering on the vision for UK health data – will deliver a triple win: for jobs, for the economy, and for the UK’s world-beating life sciences sector.”
Sunak also announced £6 billion in funding to pay for coronavirus vaccines, which is part of a package of measures designed to help the country recover from the pandemic worth £55 billion.
“As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right. Today’s funding will help them and the NHS plan for this enormous task and work together so that the right logistics are in place,” said Torbett.
The ABPI said it wants further plans including capital grants for medicines manufacturing, enhanced R&D tax credits, investment in preventive healthcare and modernisation of NICE appraisal methods to further stimulate the life sciences sector.
EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and becoming the first women in the role.
Rasi’s second five-year term came to an end on Friday (13 November), with his second stint dominated by the move of the EMA offices from London to Amsterdam – and the associated staff losses and ongoing disruption that has resulted from the UK’s withdrawal from the EU – as well as the pandemic.
Cooke will take over the EMA as the regulator is in the midst of handling the review and authorisation of medicines for COVID-19, including the first vaccines for the coronavirus, and as the regulator continues to work out its future relationship with the UK Medicines and healthcare products Regulatory Agency (MHRA) – which has been a big contributor to its expertise and workload.
Under Rasi, the EMA implemented a suite of reforms including a drive towards transparency – for example making clinical study reports (CSRs) publicly available – and the implementation of sweeping EU directives on pharmacovigilance, clinical trials and falsified medicines.
During his tenure the EMA also implemented new rules to encourage the development of advanced therapy medicinal products (ATMPs) like gene and cell therapies, and the introduction of the PRIME fast-track review for promising medicines.
Cooke is returning to the EMA after a four-year period as head of medicines regulation at the World Health Organization (WHO). She first joined the EMA in 2002 and filled a number of senior roles at the regulator including head of inspections, head of international liaison and head of international affairs before switching to the WHO in 2016.
A pharmacist by training, Cooke has also worked in the pharma industry and at European industry group EFPIA, and according to Rasi is “a strong leader who is committed to steering EMA during this very challenging period and ensuring that the agency’s work on COVID-19-related activities continues uninterrupted.”
In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”
Cooke meanwhile told Bloomberg that one of the biggest challenges she will face immediately after re-joining the EMA will be monitoring the safety of COVID-19 vaccines, particularly those that are based on new technologies like mRNA.
She also told the newswire that the EMA is adopting a different stance on gauging the efficacy of COVID-19 vaccines from the FDA, which has placed a 50% reduction in disease severity as its threshold for approval, saying guidance on its position will be published soon.
The EMA has already started reviews of Pfizer/BioNTech’s mRNA-based shot BNT162b2 and AstraZeneca/University of Oxford’s adenoviral-based candidate AZD1222.
Rasi’s first five-year term as executive director of the EMA was interrupted in 2014 when his appointment was prematurely annulled by European Union Civil Service Tribunal – on the grounds that the selection process for the post was flawed – only to resume his duties a year later.
Prior to the EMA role, Rasi was director-general of the Italian Medicines Agency from 2008, and previously spent three years as director of the Institute of Molecular Medicine in Rome.
“I am leaving EMA at a time when its mandate is set to be expanded. This is an acknowledgement of the good work and reputation that the agency has built over the last 25 years,” he said.
Businesses already struggling with the fallout from Covid-19 will be forced to deal with a mountain of new bureaucracy in the middle of a deep recession
The government did not quite achieve the Brexit breakthrough it was seeking on Friday, when there was hope that a fast-tracked trade agreement with Japan might be reached. But it seems likely that a deal, essentially replicating one signed by the EU and Japan last year, will be done by the end of the month. Some kind of morale booster for Britain’s battered and bruised businesses would certainly be welcome.
As the clock runs down to the end of the transition period on 31 December, ministers are no longer bothering to offer the false hope of a relatively frictionless trade agreement with the EU. Even a Canada-style free trade deal will mean a vast infrastructure of compliance and checks: permits for lorry drivers to enter Kent, huge customs clearance centres and tracking apps are all in the mix. The government estimates that, from 2021, there will be over 400m extra customs checks a year on goods going to and from the EU.
The UK government has asked pharma companies to build a six-week stockpile of drugs and find alternative shipping routes to the congested Dover-Calais crossing as the country heads for Brexit at the end of the year.
In a letter, Steve Oldfield, chief commercial officer at the Department of Health and Social Care, said the government is focused on preventing potential disruption to any categories of medical supplies.
Urging pharma companies to keep buffer stocks of medical supplies, Oldfield notes that global supply chains are “under significant pressure” because of the COVID-19 pandemic.
But in the letter published on the department’s website he asked companies to stockpile six weeks’ worth of stock on UK soil, adding that the department is ready to support companies with their plans if required.
One of the main issues is a pinch-point for supplies at the busy Dover-Calais shipping route, and Oldfield asked companies to look for other shipping routes amid continued speculation that Brexit could cause delays at borders with France.
David Watson, interim executive director for commercial policy at the Association of the British Pharmaceutical Industry (ABPI) said medicines companies had “worked around the clock” to ensure supply chains have been maintained during the pandemic.
He added: “With this pressure likely to continue over the coming months, it is imperative that the government works closely with (pharma companies) to provide the support they need to plan for the end of the transition period.
“While today’s letter means that preparations can proceed, detailed guidance is still urgently required from Government on issues like freight capacity, ferry routes and the Northern Ireland Protocol.”
The pharmaceutical industry has called for negotiators to seek a Mutual Recognition Agreement (MRA) – which would see both sides accept each other’s drug safety testing and inspections before export.
It is also asking for an agreement in order to avoid unnecessary duplication, disruption to supply chains or delays to patient access to medicine.
“Coronavirus has only strengthened our belief that the best possible outcome is for both sides to reach a deal that includes an MRA to protect patients and public health,” said Watson.